A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)
A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)
In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Capital Federal, Buenos Aires 1426, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires 1181, Argentina
Wuhang, Hubei 430030, China
Avignon Cedes 9, 84918, France
N.Kifissia, 14564, Greece
Wilton, CORK 0, Ireland
Kashiwa-shi, Chiba 2778577, Japan
Kurume-shi, Fukuoka 8300011, Japan
Kurashiki-shi, Okayama-ken 7108602, Japan
Hirakata-shi, Osaka 5731191, Japan
Osaka-sayama-shi, Osaka 5898511, Japan
Takatsuki-shi, Osaka 5698686, Japan
Bunkyo-ku, Tokyo 113-8603, Japan
Chuo-ku, Tokyo 1040045, Japan
Koto-ku, Tokyo 1358550, Japan
Shinjuku-ku, Tokyo 1600023, Japan
Lasi, 700106, Romania
Romania, 400015, Romania
Timisoara, Timis, 300239, Romania
Gangnam-gu, 06351, South Korea